国产依布利特转复心房颤动/心房扑动的疗效及安全性研究

Efficacy and safety of ibutilide for conversion of atrial fibrillation/flutter

目的:探讨静脉应用国产依布利特转复心房颤动(房颤)/心房扑动(房扑)的有效性和安全性。方法:筛选18～75岁,持续时间≤90 d(1 h～90 d),心室率≥60次/min的阵发性或持续性房颤/房扑患者共99例,随机分为依布利特组和普罗帕酮组各49和50例。依布利特组首剂1mg静注,如无效10 min后再给予1 mg。普罗帕酮组首剂70 mg静注,如无效10 min后再给予70mg。结果:两组均能有效降低房颤/房扑的心室率。转复率:依布利特组69.39%(34/49),普罗帕酮组44.00%(22/50),两组差异有统计学意义(P<0.05);转复时间:依布利特组显著短于普罗帕酮组(16.79±12.31)min对(36.92±11.38)min,P<0.01。不良反应:依布利特组最严重的不良反应为非持续性单形性室速,发生率6.12%(3/49),普罗帕酮组多为一过性低血压及长间歇,一例出现急性左心衰。结论:依布利特转复房颤/房扑的疗效高于普罗帕酮,转复时间短于普罗帕酮,不良反应发生率低,但须在严格监控下进行。

Objective： To investigate the efficacy and safety of intravenous ibutilide for conversion of atrial fibrillation （AF） and flutter （AFL） to sinus rhythm. Methods ： Ninety-nine consecutive patients aged 18 -75 y with AF/AFL were included. The duration of arrhythmia was 〈90 d（ 1 h -90 d） and ventricular rate was 〉 60 beats/min. Patients were assigned randomly into two groups： 49 patients in ibutilide group received ibutilide 1 mg, then repeated if AF/AFL was not converted after 10 min; 50 patients in propafenone group received propafenone 70 mg, then repeated if AF/AFL persisted after 10 min. Two drugs were diluted by 50 ml of 5% glucose and injected intravenously within 10 min. Results： Ventricular rates were decreased in both groups. AF/AFL were converted in 34 of 49 patients（69.4% ） in ibutilide group and in 22 of 50 patients（44.0% ） in propafenone group（P 〈 0.05 ）. The converting time of ibutilide was significantly shorter than that of propafenone [ （ 16.79 ± 12.31 ） min vs （36.92 ± 11.38 ） min,P 〈0.01 ]. The most serious adverse effect of ibutilide was non-sustained monomorphic ventricular tachycardia（3/49,6. 12% ）. Transient hypotension and heart pause were the main adverse events in patients who received propafenone, acute left heart failure occurred in one patient of propafenone group. Conclusions： Intravenous ibutilide is a safe and effective agent for cardioversion of recent-onset AF/ AFL. Furthermore, strict processing under electrocardio-monitoring is important.